BERLIN — Ake­so and Sum­mit’s PD-1xVEGF bis­pe­cif­ic ivonescimab cut the risk of dis­ease pro­gres­sion or death by 40% com­pared to the PD-1 block­er Tevim­bra, when both drugs were giv­en on top of chemother­a­py as a first treat­ment for cer­tain lung can­cer pa­tients.

The da­ta sug­gest that ivonescimab has the po­ten­tial to dis­place tra­di­tion­al check­point drugs in a lung can­cer in­di­ca­tion where they are wide­ly used, though more da­ta are need­ed.

The HAR­MONi-6 study was run in Chi­na, but Sun­day’s re­sults are an in­di­ca­tor of how Sum­mit Ther­a­peu­tics’ close­ly-watched glob­al Phase 3 study of ivonescimab may fare. Sum­mit, which owns rights to the drug out­side Chi­na, is test­ing ivonescimab ver­sus Mer­ck’s Keytru­da on top of chemother­a­py in the same set­ting. Both Tevim­bra and Keytru­da block PD-1, though Tevim­bra is not ap­proved for use in the US. If Sum­mit’s study suc­ceeds, then ivonescimab could up­set a par­a­digm in which the go-to treat­ment has of­ten in­clud­ed Keytru­da.

BERLIN — BioN­Tech is not mov­ing for­ward with a can­cer vac­cine in late-stage melanoma, the com­pa­ny told End­points News, though it's still un­de­cid­ed on whether it will study the can­di­date in ear­li­er-stage set­tings.

The de­ci­sion comes as the Ger­man biotech pre­sent­ed find­ings on Sat­ur­day from its Phase 2 tri­al of the ex­per­i­men­tal vac­cine known as BNT111.

Re­sults showed that while adding the can­cer vac­cine to Lib­tayo im­proved re­sponse rates, it did not help keep can­cer at bay or help pa­tients sur­vive longer. In fact, the group who re­ceived Lib­tayo alone saw bet­ter nu­mer­i­cal out­comes on sur­vival than the com­bi­na­tion arm and the group who re­ceived the can­cer vac­cine alone.

Pa­tients who re­ceived the com­bi­na­tion lived for a me­di­an 20.7 months com­pared to 22.3 months with Lib­tayo alone. And the com­bi­na­tion kept can­cer from pro­gress­ing for a me­di­an 3.1 months com­pared to 3.2 months with on­ly Lib­tayo.

Roche’s breast can­cer pill giredestrant is the first mem­ber of its class — the se­lec­tive es­tro­gen re­cep­tor de­graders, or SERDs — to prove it­self ef­fec­tive in pa­tients who do not have a mu­tat­ed ver­sion of the re­cep­tor that these drugs tar­get.

The find­ings, which are set to be pre­sent­ed Sat­ur­day at the Eu­ro­pean So­ci­ety for Med­ical On­col­o­gy's an­nu­al meet­ing in Berlin, could give Roche’s pill an ad­van­tage against the SERD pills on the mar­ket, in­clud­ing Eli Lil­ly’s new­ly ap­proved In­luriyo and Menar­i­ni’s Orser­du. Those drugs have on­ly been shown to work in pa­tients with mu­ta­tions in the gene for the ESR1 re­cep­tor, which SERDs are de­signed to in­ac­ti­vate.

BERLIN – Re­sults have been re­vealed for the much-an­tic­i­pat­ed show­down at this year’s ES­MO con­gress be­tween As­traZeneca and Dai­ichi Sankyo’s Da­troway and Gilead’s Trodelvy. Al­though Da­troway might have some edge, it seems that the two AD­Cs could be on a rough­ly equal foot­ing over­all if they are both ap­proved in the same group of breast can­cer pa­tients.

Both TROP2-di­rect­ed AD­Cs are vy­ing for the same slice of the triple-neg­a­tive breast can­cer (TNBC) mar­ket. TNBC is an ag­gres­sive form of breast can­cer, and the stan­dard of care for PD-L1-neg­a­tive pa­tients has been the same for decades. The com­pet­ing drug­mak­ers say their da­ta could change that.

BERLIN – As­traZeneca and Dai­ichi Sankyo un­veiled de­tails of a late-stage suc­cess for their block­buster drug En­her­tu in an ear­ly form of breast can­cer ahead of surgery where the com­pa­nies be­lieve it could help cure pa­tients.

In a Phase 3 tri­al called DES­TINY-Breast11, around 67% of pa­tients treat­ed with En­her­tu fol­lowed by a reg­i­men that com­bined chemother­a­py and im­munother­a­py achieved a patho­log­i­cal com­plete re­sponse (pCR), mean­ing they had no ev­i­dence of resid­ual in­va­sive dis­ease. That com­pared with about 56% of pa­tients who re­ceived the same chemother­a­py-im­munother­a­py reg­i­men to­geth­er with dose-dense dox­oru­bicin and cy­clophos­phamide.

This is the first time that